Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Difference in Number of Episodes of Genital Ulcer Disease Between Arms

Measure Description

We calculated incidence rate for each treatment arm for episodes of genital ulcer disease, and incidence rate ratio.

Time Frame

2 years

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

We conducted monthly clinical assessment for GUD on all randomized subjects during their entire follow-up period on this trial. The number of episodes of GUD is shown below.

Reporting Groups

Description

Acyclovir 400mg Tablet Twice Daily

No text entered.

Placebo Tablet Twice Daily

No text entered.

Measured Values

Acyclovir 400mg Tablet Twice Daily

Placebo Tablet Twice Daily

Participants Analyzed [Units: Participants]

220

220

Difference in Number of Episodes of Genital Ulcer Disease Between Arms [Units: Episodes]

27

47

Statistical Analysis 1 for Difference in Number of Episodes of Genital Ulcer Disease Between Arms

Groups [1]

All groups

Statistical Test Type [2]

Superiority or Other

Statistical Method [3]

rate ratio with 95% CI

P Value [4]

<0.05

Risk Ratio (RR) [5]

0.31

95% Confidence Interval

0.19 to 0.48

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Null hypothesis is no difference by treatment arm in rate of GUD.

[2]

Details of power calculation, definition of non-inferiority margin, and other key parameters:

No text entered.

[3]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[4]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

we included multiple GUD events per subject in the estimate of GUD incidence